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QCI

Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

Product code
QCI
Device name
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Device class
Class 2
21 CFR
21 CFR 882.5802
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
9 (all years; only the last 3 years are listed here)

FDA classification definition

External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-04-17.

NumberDecision dateApplicantDevice nameSummary
K2434592025-04-17Brain Ultimate, Inc.Ultimate rTMS for OCD (M-series)PDF
K2306572024-02-01BTL Industries, Inc.BTL-99-OCPDF
K2337422023-12-22Teleemg, LLCCloudTMS Edge for OCDPDF

3 summaries are archived here for direct download.

Official FDA classification page: QCI
Classification and pathway per current FDA publications. Data from openFDA (CC0).